Treating Depressed Mood With a Smartphone-delivered Positive Word Stimulation for Subthreshold Depression: Protocol for a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Profile of Mood States 2nd Edition-Adult Short (POMS 2-A Short)
研究概览
简要总结
Major depressive disorder (MDD) is an important public health problem. Thus, preventive interventions against subthreshold depression (StD), which is one of the key risk factors for the development of MDD, are important. The study developed a smartphone application (SPSRS) that improves depressive symptoms in people with StD by automatically presenting positive word stimuli during videos. The SPSRS application has the potential to improve depressive symptoms in people with StDs. However, whether it can immediately improve depressed moods in people with StD is unclear. The study aims to investigate the immediate effects of SPSRS applications on depressed mood in people with StD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female
- •20 to 39 years old
- •Beck Depression Inventory-II (BDI-II) score of 10 points or more
- •Persons with written informed consent prior to participation
排除标准
- •History of mental illness
- •Currently receiving treatment from a professional for mental health issues
- •Vision or hearing problems that interfere with daily life.
- •With a major depressive episode in the last two weeks according to the Mini-International Neuropsychiatric Interview
结局指标
主要结局
Profile of Mood States 2nd Edition-Adult Short (POMS 2-A Short)
时间窗: Change of POMS 2-A Short from baseline at the end of 10 minutes of intervention.
The POMS 2-A Short is a 35-item self-administered questionnaire used to measure mood states. Items are rated using a 5-point Likert-type scale (0 = not at all, 1 = a little, 2 = moderately, 3 = quite a lot, and 4 = extremely). The POMS 2-A Short assesses seven domains, namely, anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, vigor-activity, and friendliness. High scores indicate better vigor-activity and friendliness are better but more severe symptoms of the five other domains. In addition, the Total Mood Disturbance (TMD) score is calculated from anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, and vigor-activity. TDM is calculated based on a standard value (mean of 50 and standard deviation of 10).
次要结局
- State-Trait Anxiety Inventory State (STAI-S)(Change of STAI-S from baseline at the end of 10 minutes of intervention.)
研究者
Kazuki Hirao
Associate Professor
Gunma University